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ROCKVILLE, Md. -- Mitch Zeller may be relatively new to the role of director of the Food and Drug Administration's (FDA) Center for Tobacco Products (CTP), but his history with the regulatory agency dates back to the early 1990s. And now, he has the opportunity to continue the progress he made with tobacco regulations 20 years ago.
In an FDA webinar this afternoon entitled, "20 Years Later -- Returning to FDA to Regulate Tobacco," Zeller cited two key reasons for his return to the agency this March. No. 1, he explained, is the remaining public health challenges surrounding tobacco products. The second reason is the "stunning and rapidly evolving tobacco marketplace," he said.
Changes are coming, he noted, as tobacco companies answer consumer demand to move into smokeless products, including the "explosion" of electronic cigarettes, dissolvable products and even nicotine gel.
Under the Family Smoking Prevention and Tobacco Act passed by Congress in June 2009, the FDA is charged with four main responsibilities: prevent youth tobacco initiation; encourage adult tobacco users to quit; reduce product harm and addictiveness; and develop science-based and meaningful regulations. In addition, Zeller explained that the FDA has an opportunity to regulate other tobacco-related products under the rulemaking process, often referred to as deeming regulations.
When he joined the CTP nine months ago, Zeller inherited three top priorities. The first was to tackle the backlog of applications awaiting Substantial Equivalence (SE) approval, while the second was to move forward on the issue of menthol cigarettes.
Since his return, the CTP has made progress on both fronts. The first decisions on SE applications were handed down in June, and an advance notice of proposed rulemaking (ANPRM) related to the potential regulation of menthol in cigarettes was issued in July. FDA also released preliminary scientific evaluation of menthol use in cigarettes, and opened -- and extended -- a public comment period on the issue. The comment period ended in mid-November.
During today's webinar, Zeller declined to talk about any decisions related to menthol, only saying that the CTP's job is to now "synthesize, analyze and review" all the public comments received.
The third and final task Zeller inherited -- perhaps the most anticipated and talked about -- is the deeming regulations document. This is the next step in setting a statutory definition of a tobacco product. Zeller explained that this document was submitted to the federal Office of Management and Budget (OMB) where it is currently under review.
It is widely speculated in the tobacco industry that the deeming regulations will cover electronic cigarettes, which are not currently regulated by the FDA. Not surprisingly, Zeller declined today to discuss the specifics of the document until it is made public.
The FDA does acknowledge that different tobacco products deliver nicotine in different ways and that certain products present more individual risks than others. However, regulations come down to two basic questions, he said.
"The FDA must look at both individual level risk and population level harm, and it comes down to two questions: Who's using the product and how are they using the products?" Zeller explained. "It comes down to 'net' population effects."
For example, he said the FDA and CTP have heard from adults who have said e-cigarettes helped them quit using combustible cigarettes. But the agency cannot make regulations based on one group of people who had a good experience using any nicotine product.